AveXis: ‘Speedy scale-up driven by Novartis acquisition’

With its own facilities, support from Novartis and now dedicated space at Catalent’s Paragon, AveXis says it has the most gene therapy manufacturing capacity in the industry.

AveXis has inked a deal with contract development and manufacturing organization (CDMO) Paragon Gene Therapy to secure dedicated manufacturing space for its one-off spinal muscular atrophy (SMA) treatment Zolgensma (onasemnogene abeparvovec), approved in the US in May.

Paragon’s facility in Maryland will also provide process development for clinical supply of other gene therapy candidates in AveXis’s pipeline.

AveXis says it has the most gene therapy manufacturing capacity in the industry. Image: iStock/bankrx

“This is an important, multiyear agreement,” Andy Stober, AveXis’ chief technical officer told Bioprocess Insider, though further details relating to capacity size were not divulged.

“Paragon was an established partner we had worked with over the last few years through the development process of our first therapy [Zolgensma],” he said.

“We knew Paragon was building a new facility and they would be able to assist in further scaling our upstream process very quickly, plus we had already been working together through the development process of our first therapy.”

AveXis: ‘We have the most capacity’

Working with CDMO Paragon is important for AveXis as it allows the firm to expand and contract rapidly, Stober said. “That flexibility is important to our overall manufacturing strategy.”

However, the firm prides itself on its internal network and according to Stober: “AveXis has the most gene therapy manufacturing capacity in the industry and we’re continuing to expand capacity to meet the needs of the patients and families we serve.”

The firm has legacy facilities in Libertyville, Illinois, and San Diego, California, both of which have seen expansions as Zolgensma moved through the clinic. But much of its manufacturing ramp up has come from Novartis, which acquired AveXis for $8.7 billion (€7.7 billion) in May 2018.

“Novartis’ acquisition of AveXis a year ago has allowed us to scale more quickly, including in expanding our pipeline which will require additional manufacturing capacity,” Stobart said.

Within days of buying AveXis, the firm unveiled plans for a $55 million gene therapy production plant in Durham, North Carolina to support the gene therapy pipeline, with Novartis announcing a further $60 million into the site in February.

And in April 2019, Novartis acquired a 700,000 square-foot facility in Longmont, Colorado from AstraZeneca to support AveXis.

Further reading: ‘Zolgensma: We all know the price, but how is it made?’